ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients with Resistant Hypertension

ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients with Resistant Hypertension - ROX CONTROL HTN

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39868

Enrollment

Registered

2013-03-29

Start date

2012-10-17

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Blood Pressure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Office Systolic blood pressure >= 140 mmHg based on an average of 3 blood pressure readings;2. Ambulatory Blood Pressure Monitoring (ABPM) daytime average: • Systolic blood pressure (SBP) >= 135 mmHg; AND • Diastolic blood pressure (DBP) >= 85 mmHg ;See Protocol Section 4.4.1 for complete Inclusion Criteria

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension attributable to a cause other than sleep apnea 2. Type I diabetes See Protocol Section 4.4.2 for complete Exclusion Criteria

Design outcomes

Primary

Measure	Time frame
Primary Endpoints: - Change in 24-hour ABPM mean systolic blood pressure (SBP) at six months as compared to baseline - Change in mean office SBP at six months as compared to baseline	—

Secondary

Measure	Time frame
Secondary Endpoints: - Change in 24-hour ABPM mean diastolic blood pressure (DBP) at six months as compared to baseline - Change in mean office DBP at six months as compared to baseline - Change in mean home SBP and DBP at six months as compared to baseline - Incidence of complications directly associated with delivery and/or use of the ROX Coupler	—

Countries

Netherlands

Outcome results